Assessment of the effect of Q10 supplementation on oxidative stress in mechanically Ventilated Traumatic patients admitted to intensive care unit of Urmia Imam Khomeini hospital
Determination of the Effect of Q10 Supplementation on Oxidative Stress in Traumatic Patients under Mechanical Ventilation admitted to intensive care unit of Urmia Imam Khomeini Hospital
Design
The study was a randomized double blind randomized clinical trial with the aim of determining the supplementation of Q10 co-enzyme for 7 days. 40 traumatic patients under mechanical ventilation were randomly assigned into intervention and placebo groups using random number table with simple random sampling.
Settings and conduct
Traumatic patients under mechanical ventilation in the intensive care unit of Urmia Imam Khomeini Hospital were randomly divided into intervention and placebo groups ,and were followed up for 7 days to assessing the outcomes. The study was double-blind. The patient and the investigator were unaware about the assignment of patients in the intervention or placebo groups. the Q10 supplement was given to the patients by a person other than the investigator .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Traumatic patient under mechanical ventilation; aged 18-65; admission for at least 7 days in ICU.
Exclusion criteria: Contraindication of intestinal nutrition; Diabetes mellitus; Acute and chronic renal failure; GCS less than 9.
Intervention groups
Intervention group: co-enzyme Q 10 (100 mg) oral tablets every 4 hours (600 mg / day) for 7 days.
Placebo: starch pill for 7 days.
Main outcome variables
Oxidative stress based on assessing the SOFA score (the sequential organ Failure Assessment Score) and Serum Interleukin Level 6(IL6).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171221037983N4
Registration date:2019-03-12, 1397/12/21
Registration timing:retrospective
Last update:2019-03-12, 1397/12/21
Update count:0
Registration date
2019-03-12, 1397/12/21
Registrant information
Name
Mohammad Amin Valizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
valizademohammadamin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2018-12-21, 1397/09/30
Scientific title
Assessment of the effect of Q10 supplementation on oxidative stress in mechanically Ventilated Traumatic patients admitted to intensive care unit of Urmia Imam Khomeini hospital
Public title
Q10 supplementation on oxidative stress
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic patients under mechanically Ventilation
patients with 18-65 years
patients admitted to intensive care unit for at least 7 days
Exclusion criteria:
No Contraindication of Intestinal Nutrition
diabetic patients
Acute and chronic renal failure
GCS less than 9
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned into two intervention and placebo groups using simple random sampling. In the first, a random number was selected from the random number table. in order to complete the sample size, the even and odd numbers were assigned into two intervention and placebo groups, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was double-blind. The patient and the investigator were unaware about the assignment of patients in the intervention or placebo group. the Q10 supplement was given to the patients by a person other than the investigator .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences